Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
258 participants
INTERVENTIONAL
2011-11-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Total Dysport®
A total of 254 subjects in the open label study received between 1 and 5 intramuscular (i.m) injections of Dysport® according to their individual needs, for a period of up to 12 months. All subjects were administered an appropriate dosage of Dysport® (1000 Units \[U\] or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject's safety and efficacy response. From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U.
Botulinum toxin type A
Dysport® was supplied to the study centres in vials containing 500 U of botulinum toxin type A (BTX-A). Depending on the dose administered up to 3 vials were required for the injection.
Each vial was reconstituted with sodium chloride for injection (0.9%). A total volume of 5.0 mL of the reconstituted product was injected for Dysport® 500 U and 1000 U, and 7.5 mL was injected for Dysport® 1500 U.
Interventions
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Botulinum toxin type A
Dysport® was supplied to the study centres in vials containing 500 U of botulinum toxin type A (BTX-A). Depending on the dose administered up to 3 vials were required for the injection.
Each vial was reconstituted with sodium chloride for injection (0.9%). A total volume of 5.0 mL of the reconstituted product was injected for Dysport® 500 U and 1000 U, and 7.5 mL was injected for Dysport® 1500 U.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Study Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Associated Neurologist of Southern CT, PT
Fairfield, Connecticut, United States
Parkinson's Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Design Neuroscience Miami
South Miami, Florida, United States
The Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Mount Sinai School of Medicine
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Univ of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Medical Center
Winston-Salem, North Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Southwestern Medical Center at Dallas University of Texas
Dallas, Texas, United States
University of North Texas HSC at Ben Hogan Center
Fort Worth, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Université catholique de Louvain av Hippocrate 10
Brussels, , Belgium
Clinique Universitaire
Yvoir, , Belgium
Charles University in Prague
Prague, , Czechia
CHU Brest
Brest, , France
Centre de Réadaptation de Coubert
Coubert, , France
Centre Hospitalier Albert Chenevier-Hopital Henri Mondor
Créteil, , France
Hopital Raymond Poincarré
Garches, , France
Hôpital Sébastopol
Reims, , France
CHU Strasbourg
Strasbourg, , France
Hopital Rangueil
Toulouse, , France
Petz Aladar County Hospital
Gyor, Budapest, Hungary
National Institute for Medical Rehabilitation
Budapest, , Hungary
Azienda Hospedaliero
Catania, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
Malopolskie Centrum Medyczne
Krakow, , Poland
Krakowska Akademia Neurologii
Warsaw, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, , Poland
Medical Rehabilitation Center
Moscow, , Russia
Scientific Center of Neurology of RAMS
Moscow, , Russia
State University
Saint Petersburg, , Russia
Derer's Hospital
Bratislava, , Slovakia
Countries
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References
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Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.
Other Identifiers
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2010-019162-83
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Y-52-52120-148
Identifier Type: -
Identifier Source: org_study_id
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